Physiological and Molecular Influences of Astaxanthin Supplementation on Heat Strain in Humans

NCT02088242 | Unknown

• 2 other identifiers: SHEBA-13-0471-BA-CTILIDF-1295-2013
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Exposure to heat stress can compromise the physiological and cognitive function and be life threatening, particularly in a military setting. Various strategies of precondition to heat stress that have been explored in the past proved to be inapplicable. We aim to examine the influences of Astaxanthin supplementation as a preconditioning strategy to heat stress in a human model using a heat tolerance test. This will be achieved by a double-blind, placebo controlled supplementation trial, exposing human subjects, before and after consuming Astaxanthin or a placebo, to a controlled heat strain environment, while performing moderate exercise in a heated chamber.

Conditions

Body Temperature Regulation

Outcome Measures

Primary Outcomes (2)

• Physiological strain

  The physiological strain will be determined by monitoring body core temperature and heart rate of the subjects during a heat tolerance test (HTT) and a thermo-neutral test (TTT).The test is performed in a climatic chamber. During the test, the subject walks on a treadmill at a speed of 5 km/hr at a 2% grade for 2h. Body core temperature and heart rate are continuously monitored, and sweat rate is computed from body weight prior to and after the test, corrected for fluid intake.

  2 months for each participant

• Aerobic capacity

  The aerobic capacity of the subjects will be determined by performing a maximal oxygen consumption test (VO2max). Volunteer's oxygen consumption (VO2) will be monitored continuously with a metabolic chart (ZAN- the name of the metabolic system), while running for 10 min on a treadmill under comfortable environmental conditions.

  2 months for each participant

Secondary Outcomes (5)

• Rectal temperature

  2 months for each participant

• Skin temperature

  2 months for each participant

• Heart rate

  2 months for each participant

• Sweat rate

  2 months for each participant

• Cognitive function

  2 months for each participant

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects receiving placebo will be asked to ingest 3 capsules identical in shape, colour and size to the Astaxanthin capsules, and will contain only the inactive ingredients of the same formulation.

Drug: Placebo

Astaxanthin

EXPERIMENTAL

Subjects receiving Astaxanthin will be asked to ingest 3 capsules containing 4mg of Astaxanthin each (a daily dose of 12mg).

Drug: Astaxanthin

Interventions

Astaxanthin DRUG

Oral supplementation with the food supplement Astaxanthin. Subjects receiving Astaxanthin will be asked to ingest 3 capsules containing 4mg of Astaxanthin each (a daily dose of 12mg).

Astaxanthin

Placebo DRUG

3 capsules identical in shape, colour and size to the Astaxanthin capsules, which contain only the inactive ingredients of the same formulation.

Placebo

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy civilian volunteers.
• Aged 20-30 years.
• Without known medical illness or medication use.

You may not qualify if:

• The existence or suspicion of existing cardiac or respiratory disease.
• Hypertension.
• Diabetes.
• Any hormonal disease or any other chronic illness that may inhibit participation in the experiment.
• Infectious disease 3 days prior to the experiment.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba medical center

Tel-Hashomer, Ramat- Gan, Israel

Location

MeSH Terms

Interventions

astaxanthine

Study Officials

• Ofir Frenkel, M.D

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ofir Frenkel, M.D

CONTACT

+972529243399; Ofir.Frenkel@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head investigator of Heller institute of physiology

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 14, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 14, 2014

Record last verified: 2014-03

Locations

IL (1)